HIV (Human Immunodeficiency Virus)SG+NCT02969161
Safe Generations Plus: Swaziland PMTCT LTF Study
An observational study of HIV (Human Immunodeficiency Virus), run by Columbia University at 10 sites in Eswatini.
Trial summary
This study is to understand how to improve retention in care and treatment services to HIV positive pregnant women and their babies in Swaziland. The investigators will evaluate outcomes of patients who are lost-to-follow-up (LTF) under a new approach for prevention of mother-to-child (PMTCT) called Option B+, where… Read more about this study
- Who is it for?
- Ages 1 year to 50 years
- Conditions the study is for
- HIV (Human Immunodeficiency Virus)
- How many people
- 616 participants
- Where
- 10 sitesEswatini
- Study dates
- Mar 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: HIV-infected pregnant mothers enrolled in PMTCT care under Option B+ as part of the Safe Generations study between September 16, 2013 and August 31, 2014
Who may be able to join
- Mothers and their infants who were enrolled in PMTCT at Safe Generations study sites after the sites transitioned to Option B+.
- Determined to be LTF per the Safe Generations study protocol (i.e., have not attended a clinic visit in the 90 days prior to their 6-month postpartum appointment and are not known to be dead or transferred out, according to clinical visit data abstracted to the Safe Generations study database).
Who cannot join
- Mothers that are not a PMTCT client.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Eswatini10 sites
Family Life Association Swaziland (FLAS) Manzini
Swaziland
King Sobhuza II Hospital
Swaziland
Luyengo Clinic
Swaziland
Mankayane PHU
Swaziland
Mbikwakhe Clinic
Swaziland
Médecins sans Frontières (MSF) Matsapha
Swaziland
Raleigh Fitkin Memorial Hospital
Swaziland
Siphofaneni Clinc
Swaziland
Siteki PHU
Swaziland
Lamvelase
Zombodze
About this study
Official title: Safe Generations Plus: Mother Infant Retention Across the Option B-plus Cascade
This study is to understand how to improve retention in care and treatment services to HIV positive pregnant women and their babies in Swaziland. The investigators will evaluate outcomes of patients who are lost-to-follow-up (LTF) under a new approach for prevention of mother-to-child (PMTCT) called Option B+, where all HIV positive pregnant women initiate lifelong antiretroviral therapy (ART) regardless of their disease stage. The goal is to understand the outcomes of patients who are LTF from care, and the reasons for disengagement from care in the context of PMTCT in order to inform efforts to improve retention in care among patients under Option B+.
Read the detailed description
The study will be conducted among approximately 1,600 women and their infants who received Option B+ PMTCT services at ten facilities in Swaziland. These facilities were included in another study on Option B+ called Safe Generations in which routinely collected patient-level data was abstracted from medical registers. This study has three parts: the first is a review of alternative patient medical records among women and their infants who were documented as LTF in the Safe Generations study. The second component consists of tracing women who are LTF on the phone or in the community to administer a questionnaire. Lastly, an in-depth interview will be conducted among a sub-group of women to explore patterns of care.
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- PMTCT (Prevention of Mother-to-Child Transmission), HIV (Human Immunodeficiency Virus), Loss to follow-up (LTF), Option B+ (B+), ART (antiretroviral therapy)
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are retained in care
Confirmation of retained status among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to determine maternal reasons for leaving care.
Measured: Up to 24 months
Secondary outcomes (3)
Proportion of patients who have died
Confirmation patients being retained in care among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to capture events such as fetal loss and maternal/infant deaths that are not well documented.
Measured: Up to 24 months
Proportion of patients who are in care at another facility
Mothers and/or infants who are LTF will be traced via telephone by facility-based healthcare workers or via questionnaire/interview conducted in the community - to determine if they have transferred care to another facility (via a self-transfer of care) and therefore remain engaged in care.
Measured: Up to 24 months
Proportion of patients who have disengaged from care entirely
Confirmation of LTF status among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to capture events such as fetal loss and maternal/infant deaths that are not well documented.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 616 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Swaziland
- Responsible party
- Principal investigator, William Reidy, Columbia University
- Investigators
- William Reidy, PhD, Principal investigator, ICAP at Columbia UniversityElaine Abrams, PhD, Study director, ICAP at Columbia UniversityAverie Gachuhi, MSc, Study director, ICAP at Columbia UniversityHarriet Nuwagaba-Biribonwoha, MBChB, PhD, Study director, ICAP at Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969161
- Sponsor's protocol ID
- AAAP5700
- Acronym
- SG+
- Status last verified
- Jan 2018
- First submitted
- 17 Nov 2016
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Generations Plus: Mother Infant Retention Across the Option B-plus Cascade
- ClinicalTrials.gov ID
- NCT02969161
- Acronym / sponsor ID
- SG+ / AAAP5700
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- PMTCT (Prevention of Mother-to-Child Transmission), HIV (Human Immunodeficiency Virus), Loss to follow-up (LTF), Option B+ (B+), ART (antiretroviral therapy)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 616 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Swaziland
- Study start
- Mar 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to understand how to improve retention in care and treatment services to HIV positive pregnant women and their babies in Swaziland. The investigators will evaluate outcomes of patients who are lost-to-follow-up (LTF) under a new approach for prevention of mother-to-child (PMTCT) called Option B+, where all HIV positive pregnant women initiate lifelong antiretroviral therapy (ART) regardless of their disease stage. The goal is to understand the outcomes of patients who are LTF from care, and the reasons for disengagement from care in the context of PMTCT in order to inform efforts to improve retention in care among patients under Option B+.
Detailed description
The study will be conducted among approximately 1,600 women and their infants who received Option B+ PMTCT services at ten facilities in Swaziland. These facilities were included in another study on Option B+ called Safe Generations in which routinely collected patient-level data was abstracted from medical registers. This study has three parts: the first is a review of alternative patient medical records among women and their infants who were documented as LTF in the Safe Generations study. The second component consists of tracing women who are LTF on the phone or in the community to administer a questionnaire. Lastly, an in-depth interview will be conducted among a sub-group of women to explore patterns of care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- HIV-infected pregnant mothers enrolled in PMTCT care under Option B+ as part of the Safe Generations study between September 16, 2013 and August 31, 2014
Key inclusion criteria (2 listed)
- Mothers and their infants who were enrolled in PMTCT at Safe Generations study sites after the sites transitioned to Option B+.
- Determined to be LTF per the Safe Generations study protocol (i.e., have not attended a clinic visit in the 90 days prior to their 6-month postpartum appointment and are not known to be dead or transferred out, according to clinical visit data abstracted to the Safe Generations study database).
Key exclusion criteria (1 listed)
- Mothers that are not a PMTCT client.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients who are retained in care
Time frame: Up to 24 months
Confirmation of retained status among all Option B+ mothers and their infants who are identified as LTF per the Safe Generations study through review of facility-based records - to determine maternal reasons for leaving care.
3 secondary outcomes
Proportion of patients who have died
Time frame: Up to 24 months
Proportion of patients who are in care at another facility
Time frame: Up to 24 months
Proportion of patients who have disengaged from care entirely
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Reidy, PhD principal investigator
ICAP at Columbia University
Elaine Abrams, PhD study director
ICAP at Columbia University
Averie Gachuhi, MSc study director
ICAP at Columbia University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV (Human Immunodeficiency Virus), run by Columbia University at 10 sites in Eswatini.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Eswatini. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who are retained in care (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2018.